Nexplanon Observational Risk Assessment Study (NORA)

Study type

• Study topic:
  Human medicinal product

  Disease /health condition
• Study type:
  Non-interventional study
• Scope of the study:
  Assessment of risk minimisation measure implementation or effectiveness

  Drug utilisation
• Data collection methods:
  Primary data collection

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Study drug International non-proprietary name (INN) or common name:
  ETONOGESTREL

  BARIUM SULFATE
• Medical condition to be studied:
  Contraception

Population studied

• Short description of the study population:
  Women with a newly-inserted Nexplanon contraceptive implant.
• Age groups:
  Adolescents (12 to < 18 years)

  Adults (18 to < 46 years)
• Estimated number of subjects:
  7100

Study design details

• Main study objective:
  The primary objective of the study is to characterize the frequency of specific insertion-, localization- and removal-related events and clinically significant consequences thereof among Nexplanon users in the US during standard clinical practice.
• Outcomes:
  - Characterize the insertion-, localization- and removal-related events, including incorrect insertion, localization of non-palpable implants and difficult removals- Describe the clinically significant consequences of these events, including pregnancy due to unrecognized non-insertion, injury to neurovascular structures in the arm and hospitalisation/surgery for localization/removal events, to monitor the occurrence of pregnancy and pregnancy outcomesto describe the reasons for (premature) discontinuation of Nexplanonto describe the baseline characteristics of Nexplanon users
• Data analysis plan:
  Characterization of the frequency of specific insertion-, localization- and removal-related events among Nexplanon users under standard clinical practice will mostly be undertaken via point-estimates of the event rates as well as 95% confidence intervals. The impact of potential prognostic factors will be analyzed using multivariate regression models and/or stratified analyses. A complete data analysis plan, included mock tables will be developed within the next six months.

Documents

Study results

NORA_Final Report